Nu-Cath Emergency Kit
FDA 510(k) K850398 · Intl. Medical Devices , Ltd.
510(k) numberK850398
Submission
- Device name
- Nu-Cath Emergency Kit
- Applicant
- Intl. Medical Devices , Ltd.
Los Angeles, CA, US - Received
- February 1, 1985
- Decision date
- March 27, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FOZ – Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5200
- Specialty
- General Hospital
Other 510(k)s with product code FOZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260432 | Ruby Intravascular CatheterFOZ · Traditional | Venocare, Inc. | 09/02/2026SE |
| K260165 | Unimpregnated Central Venous CatheterFOZ · Traditional | Spectrum Vascular | 08/10/2026SE |
| K261041 | ClearSafe Closed SystemFOZ · Traditional | MedSource Labs, LLC | 07/10/2026SE |
| K260539 | MedSource QuickSafe Safety IV Catheter; MedSource PurSafe Safety IV CatheterFOZ · Traditional | MedSource Labs, LLC | 07/09/2026SE |
| K253235 | Introcan Safety® Deep Access XL IV CatheterFOZ · Traditional | B.Braun Medical, Inc. | 05/15/2026SE |
| K252137 | BD Insyte IV CatheterFOZ · Traditional | Becton Dickinson Infusion Therapy Systems, Inc. | 04/02/2026SE |
| K252513 | Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm…FOZ · Special | Poly Medicure Limited | 04/01/2026SE |
| K252398 | SURFLO Hybria Closed System Safety IV CatheterFOZ · Traditional | Terumo Medical Products (Hangzhou) Co., Ltd. | 12/17/2025SE |
| K252677 | Polyshield Safety IV CathetersFOZ · Special | Poly Medicure Limited | 11/05/2025SE |
| K251422 | BD Saf-T-Intima Subcutaneous Catheter SystemFOZ · Traditional | Becton Dickinson Infusion Therapy Systems, Inc. | 10/08/2025SE |
More from Becton Dickinson Infusion Therapy Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K913541 | Neo-Thor Thoracostomy KitFMF · Traditional | 04/09/1992SE |
| K913540 | Pedia-Thor Thoracostomy KitFMF · Traditional | 04/09/1992SE |
| K913542 | Thoracic Catheter with GuideGBX · Traditional | 01/21/1992SE |
| K913539 | Thoracic Cathter StyletGBX · Traditional | 01/21/1992SE |
| K913543 | Thoracic Catheter StyletDRB · Traditional | 10/04/1991SE |
| K862909 | Re-Trake Weiss Emergency Airway & Thoracic SystemBTO · Traditional | 09/09/1986SE |
| K843785 | Wisss Pediatric Trach- Tube W/ObturatorBTO · Traditional | 10/23/1984SE |
| K842666 | Nu-Thor Thoracostomy KitKGZ · Traditional | 09/20/1984SE |
| K840925 | Pedia-Trake Cricothyrotomy KitBTO · Traditional | 05/02/1984SE |
| K820778 | Respiration Monitor 1000BZQ · Traditional | 05/03/1982SE |
Questions and answers
When was Nu-Cath Emergency Kit cleared by the FDA?
Nu-Cath Emergency Kit (K850398) received a 510(k) decision of Substantially Equivalent on March 27, 1985, 54 days after the submission was received.
What is the product code of K850398?
The FDA product code is FOZ – Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, a Class II (moderate risk) device regulated under 21 CFR 880.5200.